Chronology of Occult and Gross Coagulopathy in Burn Patients
This study is not yet open for participant recruitment.
Verified July 2012 by Medstar Research Institute
Sponsor:
Medstar Research Institute
Collaborator:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01638481
First received: July 9, 2012
Last updated: July 10, 2012
Last verified: July 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 9, 2012 | ||||
| Last Updated Date | July 10, 2012 | ||||
| Start Date ICMJE | July 2012 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01638481 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chronology of Occult and Gross Coagulopathy in Burn Patients | ||||
| Official Title ICMJE | Determining the Chronology of Occult and Gross Coagulopathy in Thermally Injured Patients: A Systems Biology Approach | ||||
| Brief Summary | The purpose of the study is to identify the inflammatory and coagulation pathways and mechanisms that are activated immediately following burn injury, and how they affect outcomes in terms of organ failure and death. This study also addresses the limitation of current tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances in severely injured patients both in a comprehensive and rapid manner. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Burn injury patients will be enrolled in the study upon arrival at Trauma Center. |
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| Condition ICMJE | Thermal Burns | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 85 | ||||
| Estimated Completion Date | June 2016 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01638481 | ||||
| Other Study ID Numbers ICMJE | 58802-LS | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Medstar Research Institute | ||||
| Study Sponsor ICMJE | Medstar Research Institute | ||||
| Collaborators ICMJE | Department of Defense | ||||
| Investigators ICMJE |
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| Information Provided By | Medstar Research Institute | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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